Amino Acids, Carbohydrates, Electrolytes, Vitamins
For Intravenous Administration
AMINOVEL® 600 is a well-balanced mixture of L-Amino acids optimally proportioned for maximum protein synthesis. Sorbitol, vitamins and electrolytes supplement or nutritional needs for the body.
|COMPOSITION (Each 500 mL contains):|
|Amino acids (L-form)||25.0||g||Sodium||35||mEq/L|
|Riboflavin Sodium Phosphate||1.25||mg|
|Water for Injection||ad 500 mL||Osmolarity||Approx.1160 mOsm/L|
CONTENTS OF 25.0 g AMINO ACIDS:
|L-Leucine||1.20||g||L-Arginine (calculated as base)||3.10||g|
|L-Lysine (calculated as base)||1.00||g||L-Histidine (calculated as base)||0.50||g|
AMINOVEL® 600 is a sterile aqueous solution supplying approx. 600 calories per liter. Each lot is examined by exothermic substance test, sterility test and toxicity test and is manufactured under the severe standard.
INDICATIONSAMINOVEL® 600 is recommended for parenteral nutrition supply in the following conditions:
- As supplement nutrition in the case of the impairment of the gastrointestinal tract as in clinical situation of short bowel syndrome, anorexia and severe gastrointestinal disorder.
- Prolonged gastrointestinal rest is necessary as in case of enterocutaneous fistulae and involving the gastrointestinal tract.
- In increased metabolic need as in the cases of severe burns, trauma and after surgery.
- In other critical cases, which require exogenous nutrition such as tumor, severe infections, severe stress and protein deficiency.
Patients with hypersensitivity to one of the components of solution.
DOSAGE AND ADMINISTRATION
- For internal disorder or presurgical protein deficiency: The usual adult dosage is 500 mL of AMINOVEL® 600 by intravenous drip infusion over 4-6 hours (20-30 drops per minute) simultaneously or followed by a 10% sugar solution 500 mL over 2 hours (60-80 drops per minute). These infusions are repeated at 12 hours intervals for 5-7 days.The intervals may be prolonged to 24 hours according to patients condition and response.
- For post surgical impairment of protein synthesis: The usual adult dosage is 500 mL of AMINOVEL® 600 by intravenous drip infusion over 4-6 hours (20-30 drops per minute) following drip infusion of Darrow's solution 1000 mL over 4 hours (60-100 drops per minute) and followed by drip infusion of a 10% sugar solution 500 mL over 2 hours (60-100 drops per minute). These infusions are started on the third post surgical day and repeated at 24 hours intervals for 5-7 days.
AMINOVEL® 600 supplies the following essential components for parenteral nutrition:
- L-forms of amino acids which can be only utilized in the body for the synthesis of its various protein constituents; It is known that the body does not normally preserve nitrogen balance with D-isomers of amino acids.
- The eight essential amino acids: L-Isoleucine, L-Leucine, L-Lysine, L-Methionine, L-Phenylalanine, L-Threonine, L-Tryptophan and L-Valine are indispensable for protein synthesis.
- The semi essential amino acids:
- L-Histidine utilizes optimally amino acid mixtures and is essential for infants and in uraemia;
- L-Arginine utilizes optimally amino acid mixtures and is essential for detoxication.
- L-Alanine and L-Proline are necessary for optimal utilization of amino acid mixtures.
- Glycine is a source for nonspecific nitrogen.
- Sorbitol to supply sufficient non nitrogen calories to meet metabolic energy requirements.
- Vitamins to prevent deficiencies and to promote the bio synthesis of protein.
- Minerals to maintain electrolyte balance and to promote synthesis of protein.
- Water to meet the body's requirements.
- Careful checking should be done for urine volume not to be less than 60-70 mL per hour and reexamination of dosage schedule is necessary when the volume falls below the level.
- Use immediately after breaking the seal and do not use the remaining solution.
- Take special care of handling the instruments for injection as these preparation are liable to propagate germs.
- Open the outer wrap just before use.
- Do not use if bag is leaking, solution cloudy or contains foreign matters. I
- Maximum infusion rate is 3 cc per minute.
Store below 30°C, protect from light
Box, 1 soft bag of 500 mL
REG NO.: DKL9218702749A1
ON MEDICAL PRESCRIPTION ONLY
HARUS DENGAN RESEP DOKTER
PT. Otsuka Indonesia
Jl. Sumber Waras No. 25
Lawang, Malang 65216, Indonesia